Fresenius Kabi USA, LLC recalled 5% Dextrose Injection, USP, 50 mL in a 100 mL freeflex bag, distributed nationwide including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Consumers and healthcare providers should stop using this product immediately and contact Fresenius Kabi for guidance.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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5% Dextrose Injection is a sterile IV fluid used to provide calories and fluids. It is commonly used in hospitals for various IV therapies.
A lack of sterility can introduce bacteria or other contaminants into IV solutions, posing infection risk to patients.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to quarantine lots, notify patients, and switch to alternative sterile IV solutions.
FDA enforcement report D-0435-2026 and Fresenius Kabi recall communications
Facility-level recalls typically resolve within weeks; hospitals may implement replacements within 4-8 weeks
Keep recall letters, batch numbers, and communications with suppliers for records
Product: 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL). Bag: 50 mL in a 100 mL freeflex bag. NDCs: Unit of Use 65219-456-05; Unit of Sale 65219-456-60. Batch: 6402296. Expiration: 07/31/2026. Sold in the US nationwide, including Alaska and Puerto Rico. Company: Fresenius Kabi USA, LLC. Recall date: 2026-03-11. Status: ACTIVE.
No specific incident counts are provided in the notice. The FDA page lists the issue but does not mention injuries or adverse events.
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Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP IV solution in freeflex bags due to lack of assurance of sterility. The recall affects batches 6402399, 6402400, and 6402401 with Exp 02/28/2027. Distributors nationwide, including Alaska and Puerto Rico, are notified. Stop using and contact the company for guidance and potential replacement.
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 12.5 g per 250 mL in FreeFlex bags due to lack of sterility assurance. The recall covers units distributed nationwide including Alaska and Puerto Rico. Healthcare providers and patients should stop use and consult a healthcare professional.